A comparison of diagnostic performance between two quantitative rapid fecal calprotectin assays in detecting active inflammatory bowel disease

PLoS One. 2021 Aug 12;16(8):e0255974. doi: 10.1371/journal.pone.0255974. eCollection 2021.

Abstract

Background: Fecal calprotectin (FC) is widely used for the diagnosis and monitoring disease activity of inflammatory bowel disease (IBD). Quantitative rapid assays can be a reliable alternative to the time-consuming assay. This study aimed to evaluate and compare the diagnostic performance of two quantitative rapid FC assays (Ichroma calprotectin, and Buhlmann Quantum blue).

Methods: A total of 192 patients were included in this study; 84 patients with IBD (67 ulcerative colitis and 17 Crohn's disease) and 108 patients with non-IBD. We compared quantitative FC levels in different disease statuses and evaluated the correlation between the FC results of the two FC kits. Diagnostic performances in predicting active IBD were evaluated in reference to different cut-off levels.

Results: The FC levels in 45 patients with active IBD as defined by endoscopic score were significantly higher compared to the inactive IBD and other diseases (P<0.05). Although the two assays' results correlated (r = 0.642, P < 0.001), a significant deviation was observed (y (Buhlmannn) = -45.2 +8.9X (Ichroma)). The Diagnostic performances in predicting active IBD were comparable as area under the curve (AUC), 0.812, cut-off, 50, sensitivity, 64.4%, and specificity, 85.0% for iChroma assay and AUC, 0.826, cut-off, 100, sensitivity, 84.4%, and specificity 61.9% for Buhlmann Quantum Blue assay. FC levels using a cut-off of > 250 μg/g confirmed 85.7% (iChroma) and 64.1% (Buhlmann) of active IBD patients.

Conclusion: The results of the two rapid FC assays iChroma and Buhlmann showed a significant correlation, but the two test results were not interchangeable. With optimized cut-off values, rapid FC tests could be helpful in the diagnosis of IBD and differentiating active IBD from inactive or organic bowel disease.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Biomarkers / metabolism*
  • Case-Control Studies
  • Child
  • Diagnostic Tests, Routine / classification
  • Diagnostic Tests, Routine / methods*
  • Enzyme-Linked Immunosorbent Assay
  • Feces / chemistry*
  • Female
  • Humans
  • Inflammatory Bowel Diseases / diagnosis*
  • Inflammatory Bowel Diseases / metabolism
  • Leukocyte L1 Antigen Complex / analysis
  • Leukocyte L1 Antigen Complex / metabolism*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Severity of Illness Index*
  • Young Adult

Substances

  • Biomarkers
  • Leukocyte L1 Antigen Complex

Grants and funding

Dr. E-JO was supported by a National Research Foundation of Korea grant funded by the Korean government (MSIP) (NRF-2020R1A2B5B01001859). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.